দেশ: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Nevirapine 200mg (based on 100% assay and nil water content);
Viatris Limited
Nevirapine 200 mg (based on 100% assay and nil water content)
200 mg
Tablet
Active: Nevirapine 200mg (based on 100% assay and nil water content) Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified water Sodium starch glycolate
Blister pack, PVC/Alu, 60 tablets
Prescription
Prescription
Mylan Laboratories Limited
Use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Resistant virus emerges rapidly and uniformly when nevirapine is administered as monotherapy. Therefore, it should always be administered in combination with at least two additional antiretroviral agents.
Package - Contents - Shelf Life: Blister pack, PVC/Alu - 60 tablets - 48 months from date of manufacture stored at or below 25°C. Store in orginal packaging - Bottle, plastic, HDPE - 60 tablets - 48 months from date of manufacture stored at or below 25°C. Store in orginal container
2009-12-21
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION NEVIRAPINE VIATRIS _NEVIRAPINE TABLETS 200 MG_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nevirapine Viatris. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Nevirapine Viatris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NEVIRAPINE VIATRIS IS USED FOR Nevirapine Viatris is used in combination with other antiretroviral medicines to slow down the progression of Human Immunodeficiency Virus (HIV) infection. HIV can lead to Acquired Immunodeficiency Syndrome (AIDS) and other related illnesses. Nevirapine Viatris contains the active ingredient Nevirapine. It belongs to a group of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Nevirapine works by inhibiting or interrupting the enzyme reverse transcriptase that the HIV virus uses to multiply. Nevirapine Viatris does not cure or prevent HIV infection or AIDS, but it does hinder the growth of HIV. In this way it stops ongoing damage to the body’s immune system, which fights infection. Nevirapine Viatris is prescribed in combination with other antiretroviral medicines which hinder the growth of HIV in other ways. When these medicines are taken with Nevirapine Viatris, the growth of HIV is hindered more effectively. Nevirapine Viatris does not prevent or reduce your risk of passing HIV infection to others. You will still be able to pass on the HIV virus by sexual activity or by passing on blood or bodily secretions which carry the HIV virus. You should continue to take all appropriate precautions. While taking Nevirapine Viatris and any other therapy for HIV, you may continue to develop other infections and other complications সম্পূর্ণ নথি পড়ুন
Page 1 of 31 NEW ZEALAND DATA SHEET NEVIRAPINE VIATRIS 1. PRODUCT NAME Nevirapine Viatris 200 mg tablet, uncoated. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of nevirapine. Excipient with known effect: lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nevirapine Viatris 200 mg tablets are white to off-white, oval shaped, biconvex uncoated tablets, debossed with “NE 200” with a single bisect separating the “NE” and “200” on one side and debossed with “M” with a single bisect separating the “M” on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Nevirapine Viatris is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Resistant virus emerges rapidly and uniformly when nevirapine is administered as monotherapy. Therefore, Nevirapine Viatris should always be administered in combination with at least two additional antiretroviral agents. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE _ADULTS 16 YEARS AND OLDER_ The recommended dose for Nevirapine Viatris is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents. For concomitantly administered nucleoside therapy, the manufacturer's recommended dosage and monitoring should be followed. Patients should be advised of the need to take Nevirapine Viatris every day as prescribed. If a dose is missed the patient should not double the next dose but should take the next dose as soon as possible. Page 2 of 31 _MONITORING OF PATIENTS_ Clinical chemistry tests, which include liver function tests, should be performed prior to initiating nevirapine therapy and at appropriate intervals during therapy. It is strongly recommended to monitor liver function every two to three weeks in the সম্পূর্ণ নথি পড়ুন